Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients

Phase 4

• Conditions: Overactive Bladder Syndrome
• Interventions: Drug: Solifenacin for 24 weeks; Drug: Solifenacin for 12 weeks

• Registration Number: NCT01876186
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.

Detailed Description

Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the first-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efficacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.

The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-05
• Last Update Posted: 2015-07-07
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women who have overactive bladder syndrome

Exclusion Criteria

• Women who are less than 20 year-old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Solifenacin for 24 weeks group	Solifenacin for 24 weeks	Solifenacin (5 mg qd) for 24 weeks
Solifenacin for 12 weeks group	Solifenacin for 12 weeks	Solifenacin (5 mg qd) for 12 weeks

Primary Outcome Measures

Name	Time	Method
The rate of normalized urodynamic findings	6 months	The rate of normalized urodynamic finding after antimuscarinics

Secondary Outcome Measures

Name	Time	Method
The cure rate of overactive bladder	24 weeks	The cure rate of overactive bladder after antimuscarinics
The recurrence rate of overactive bladder	2.5 years	The recurrence rate of overactive bladder after antimuscarinics
The difference of urine nerve growth factor level	24 weeks	The difference of urine nerve growth factor level after antimuscarinics

Trial Locations

Locations (1)

Department of Obstetrics & Gynecology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan